PROCAL TECHNOLOGIES · 9 hours ago
Validation Engineer - W2 Role
Round Lake, IL
Contract
Onsite
Senior Level
5+ years expPROCAL TECHNOLOGIES is seeking a Lab Equipment Validation Engineer to lead validation efforts for laboratory equipment supporting infusion system testing. The role involves developing validation protocols and collaborating with various teams to ensure compliance with FDA regulations and best practices in equipment validation.
Cloud ComputingConsultingBig DataInformation Technology
Hiring Manager
Anwar M.
Responsibilities
Lead validation efforts for laboratory equipment supporting infusion system testing (e.g., Infuscale, altitude chambers, environmental chambers, flow measurement instruments, and related test systems)
Develop and execute validation protocols, test plans, and reports in alignment with FDA 21 CFR Part 820, Part 11, ISO 13485, and equipment validation best practices
Partner with R&D, Quality, and Systems Engineering teams to define equipment validation requirements and risk‑based strategies
Perform IQ/OQ/PQ activities for lab equipment and ensure complete traceability from requirements through test execution
Ensure validated equipment supports all infusion system verification needs including flow accuracy, environmental stress testing, and performance simulation
Collaborate with hardware, firmware, and systems engineering teams to ensure equipment suitability and proper test coverage
Investigate and resolve equipment issues discovered during validation or testing activities
Support calibration, maintenance, and lifecycle management of lab equipment used for infusion system tests
Drive continuous improvement of validation processes, documentation quality, and lab test methodologies
Maintain accurate and compliant documentation per Baxter quality systems, design control, and equipment lifecycle standards
Qualification
Required
Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, Computer Engineering, or related technical field
Minimum 5+ years of experience in equipment validation or software validation within a medical device or FDA‑regulated environment
Strong understanding of FDA regulations, ISO 13485, equipment validation, and regulated testing processes
Hands-on experience with lab equipment used in infusion system testing: Infuscale, altitude chambers, environmental chambers, flow measurement instruments, and similar test systems
Hands-on experience with tools such as LabVIEW or Python for automating test data acquisition (as applicable)
Hands-on experience with test measurement instruments such as temperature chambers, flow analyzers, pressure sensors, oscilloscopes, and calibration tools
Hands-on experience with risk management frameworks (ISO 14971)
Hands-on experience working within formal document control, change management, and validation documentation systems
Preferred
Prior experience validating lab equipment specifically for infusion systems or drug delivery devices
Knowledge of environmental and stress testing methodologies for medical device performance verification
Familiarity with data integrity and cybersecurity considerations in lab test environments
Certifications such as CSQE, CMII, or Lean Six Sigma are a plus
Company
PROCAL TECHNOLOGIES
Procal Technologies is an information technology services and business applications consulting company.
201-500 employees
H1B Sponsorship
PROCAL TECHNOLOGIES has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (31)
2023 (44)
2022 (46)
2021 (41)
2020 (103)
Funding
Current Stage
Growth StageLeadership Team
Venkat Pasula
CEO
Company data provided by crunchbase